Speedel Reports Successful SPP635 Phase IIa Trial in Hypertension
Next Generation Renin Inhibitor to Continue Phase II Profiling in Diabetic Patients
BASEL/Switzerland and BRIDGEWATER NJ/USA, 28 June 2007-Speedel
(SWX: SPPN) today announced that it has reached another significant
milestone in the development of its family of renin inhibitors with
the successful completion of a Phase IIa proof-of-concept clinical
trial with SPP635 for the treatment of hypertension. Based on these
positive results, the company is to continue developing SPP635 in
Phase II in a special population of diabetic patients with
mild-to-moderate hypertension. This compound is the first of a next
generation of renin inhibitors following Speedel's lead product
SPP100 (aliskiren, Tekturna/Rasilez[1]), which is partnered with
Novartis and recently obtained US marketing approval from the FDA
and a positive opinion from the CHMP in Europe[2]. SPP635 is the
most advanced compound in the SPP600 series and is one of several
new proprietary renin inhibitors invented by Speedel Experimenta,
the company's late-stage research unit.
Phase IIa results demonstrate strong efficacy and good
tolerability
The trial had a double-blind, placebo-controlled, randomised,
parallel design and it evaluated patients treated with a single
dosage level of SPP635 once-daily for 4 weeks. It studied the
safety and efficacy of SPP635 in 35 male and female patients (20
patients receiving SPP635 and 15 receiving placebo) with
mild-to-moderate hypertension by measuring office and ambulatory
blood pressure[3].
SPP635 was safe and well tolerated over the 4 week period. There
were no serious adverse events reported nor were there any
clinically significant changes in laboratory safety parameters.
Sitting systolic blood pressure was significantly reduced by 17.9
mmHg from 156.6±9.1 mmHg at baseline (mean ± SD) to
138.7±13.3 mmHg in the SPP635 treated group after 4 weeks
(p<0.001). The placebo group remained unchanged
(156.1±9.0 to 153.2±8.9 mmHg; baseline vs. end of
treatment). Diastolic blood pressure was also significantly reduced
by 9.8 mmHg from 91.3±7.8 to 81.5±8.2 mmHg
(p<0.001) in the SPP635 treated group compared to the placebo
treatment (95.3±5.1 to 93.3±5.4 mmHg). These blood
pressure measurements were taken at trough, 24 hours after the
previous medication. Similar results were observed for ambulatory
blood pressures, which were reduced both during the day as well as
in the night.
The half-life of SPP635 had been previously reported to be
approximately 24 hours suggesting once daily administration; these
latest ambulatory blood pressure data confirm the use as of SPP635
as an once-a-day drug. The extent of blood pressure reduction is
similar to those reported for the renin inhibitor SPP100
(aliskiren,Tekturna/Rasilez)[4].
Hans R. Brunner, Professor Emeritus of Medicine at the University
of Lausanne, and acting Speedel Medical Director, commented: "These
positive results show that SPP635 has comparable efficacy to other
blood pressure lowering therapies. It will be exciting to see the
first follow-on renin inhibitor to SPP100 demonstrate its potential
in diabetic patients in further clinical trials."
Alice Huxley, CEO of Speedel, commented: "This success with SPP635
reinforces Speedel's strategy of building a family of renin
inhibitors which can be profiled for both general and special
patient populations. We continue to leverage our exceptional
knowledge in renin inhibition which we believe has the potential to
be the next gold standard for the treatment of different
cardiovascular diseases."
Continued Phase II development
Clinical profiling of SPP635 will continue this year in special
populations with a further study planned in diabetic patients with
mild-to-moderate hypertension. This harder to manage patient group
has been shown to respond to SPP100 to controlling blood pressure
alone and in combination with an ACE-I[5][6]. Further details about
this proof-of-concept Phase II trial will be announced later in
2007 when it commences. The trial will be carried out in Europe
with results due in the second half of 2008.
Speedel's next generation renin inhibitors include other compounds
in the SPP600 series, the SPP1100 series with SPP1148 due to report
first Phase I results in Q42007, and the SPP800 series currently in
late-stage pre-clinical profiling. Each series is a different
chemical class with distinct properties and is protected by
different patent applications.
About SPP600 series
SPP635 is the most advanced compound of the SPP600 series of renin
inhibitors being developed by Speedel. The company has made
significant progress in the optimisation and development of this
series of newly synthesised compounds by using rational drug
design, including computer assisted molecular modelling techniques,
state-of-the art preclinical disease models and human
microdosing.
In December 2001, Speedel acquired a worldwide exclusive license
from Roche covering its entire programme in renin inhibition. This
license allows Speedel to use the acquired know-how for lead
optimisation of its own compounds designated as the SPP600 series.
Speedel holds full development and commercialization rights for
these product candidates under the license agreement with Roche. If
Speedel decides to offer rights to any Speedel compound from the
series to a third party, Roche has a right of first negotiation
with respect to such rights. If Roche has not expressed its
interest in acquiring such rights within a defined period of time,
or the parties have not reached an agreement on the terms of such
rights, Speedel is free to grant such rights to any third
party.
About Hypertension
Hypertension is a common disorder in which blood pressure is
abnormally high, placing undue stress on the heart, blood vessels
and other organs such as the kidney and the brain. Blood pressure
is determined in two phases as the heart contracts and relaxes.
Systolic blood pressure represents the force that blood exerts on
the walls of arteries as the heart contracts to pump out blood.
Diastolic blood pressure represents the force as the heart relaxes
to allow the blood to flow into the heart.
Due to its wide prevalence and impact on cardiovascular health,
hypertension is a major cause of disease and death in Europe and
North America. More than one in three Europeans and North Americans
over the age of 35 suffers from hypertension - but for the vast
majority of patients who undergo hypertension treatment, the causes
of high blood pressure are unknown. More than 40 % of patients
undergoing treatment with current therapies do not reach targeted
blood pressure levels, and so there is a considerable unmet medical
need.
The latest potential therapeutic agents for hypertension are renin
inhibitors. Renin is an enzyme produced in the kidneys in response
to reduced renal perfusion. Through a cascade of biological events,
renin acts to bring about sodium retention, an increase in blood
pressure, and restoration of renal perfusion, which shuts off the
signal for renin release. For hypertensive individuals, renin
inhibitors are currently being investigated as a therapy that may
provide benefits over current therapies to reduce blood pressure,
decrease salt retention and may protect end organs such as the
kidney, heart and brain.
About Speedel
Speedel is a public biopharmaceutical company that seeks to create
value for patients, partners and investors by developing innovative
therapies for cardiovascular and metabolic diseases. Speedel is a
world leader in renin inhibition, a promising new approach with
significant potential for treating cardiovascular diseases. Our
lead compound SPP100 (Tekturna/Rasilez [i]), the first-in-class
direct renin inhibitor, was in-licensed from Novartis in 1999 and
licensed-back to Novartis Pharma in 2002 for further development
and commercialisation; SPP100 was approved by the FDA in the US in
March 2007, and filed by Novartis with the EMEA in the EU in Q3
2006. Our pipeline covers three different modes of action, and in
addition to SPP100, includes SPP301 in Phase III (on hold), SPP200
in Phase II, SPP635 in Phase Il, SPP1148 in Phase I and several
pre-clinical projects.
Speedel develops novel product candidates through focused
innovation and smart drug development from lead identification to
the end of Phase II. We either partner with big pharma for Phase
III and commercialisation in primary-care indications, or we may
ourselves complete Phase III development in specialist indications.
Candidate compounds for development and the company's intellectual
property come from our late-stage research unit Speedel Experimenta
and from in-licensing. Our team of approximately 70 employees,
including over 30 experienced pharmaceutical scientists, is located
at our headquarters and laboratories in Basel, Switzerland and at
offices in New Jersey, USA and Tokyo, Japan.
In January 2007 the company raised gross proceeds of CHF 55.5
million (approximately EUR 34.3 million or USD 44.5 million)
through a convertible bond issue. In March 2006 the company raised
gross proceeds of CHF 83.95 million (approximately EUR 53m or USD
64m) through the public offering of 500,000 treasury shares.
Previously, as a private company, we raised gross proceeds of CHF
255 million (approximately EUR 157 million or USD 204 million) from
private placements of equity securities and two convertible loans
including the conversion premiums. We have had total revenues,
principally from milestone payments, of CHF 57.7 million
(approximately EUR 37 million or USD 44 million). The company's
shares were listed in September 2005 on the SWX Swiss Exchange
under the symbol SPPN.
Forward looking statements
This press release includes forward-looking statements that involve
substantial risks and uncertainties. These forward-looking
statements are based on our current expectations and projections
about future events. All statements, other than statements of
historical facts, regarding our strategy, future operations, future
financial position, future revenues, projected costs, prospects,
plans and objectives of management are forward-looking statements.
The word "may" and similar expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words. We may not actually
achieve the plans, intentions or expectations described in these
forward-looking statements and you should not place undue reliance
on them. There can be no assurance that actual results of our
research and development activities and our results of operations
will not differ materially from these expectations. Factors that
could cause actual results to differ from expectations include,
among others: our or our partners' ability to develop safe and
efficacious products; our or our partners' ability to achieve
positive results in clinical trials; our or our partners' ability
to obtain marketing approval and market acceptance for our product
candidates; our ability to enter into future collaboration and
licensing agreements; the impact of competition and technological
change; existing and future regulations affecting our business;
changes in governmental oversight of pharmaceutical product
development; the future scope of our patent coverage or that of
third parties; the effects of any future litigation; general
economic and business conditions, both internationally and within
our industry, including exchange rate variations; and our future
financing plans.
[1] Tekturna® and Rasilez® are Novartis trademarks in
the USA and Europe, respectively
[2] Food and Drug Administration (FDA) and Committee for Medicinal
Products for Human Use (CHMP)
[3] Ambulatory blood pressure is measured by a portable device worn
by the patient over 24 hours at pre-determined intervals
Office blood pressure (systolic and diastolic) is measured
when the patient is in the physician's office at pre-determined
intervals
[4] Aliskiren Reduces Blood Pressure and Suppresses Plasma Renin
Activity in Combination With a Thiazide Diuretic, an
Angiotensin-Converting Enzyme Inhibitor, or an Angiotensin Receptor
Blocker O'Brien E; Barton J; Nussberger J; Mulcahy D; Jensen C;
Dicker P; Stanton A, Hypertension. 2007;49:276-284.
[5] Angiotensin Converting Enzyme Inhibitor
[6] Uresin Y et al. Aliskiren, a novel renin inhibitor, has greater
BP lowering than ramipril and additional BP lowering when combined
with ramipril in patients with diabetes and hypertension. European
Society of Hypertension. 16th European Meeting on Hypertension.
June 12-15, 2006; Madrid, Spain.
[i] Tekturna/Rasilez® are Novartis trademarks
For further information please contact
Nick Miles
Director Communications & Investor Relations
Speedel
Hirschgässlein 11
CH - 4051 Basel
Switzerland
T +41 (0) 61 206 40 00
D +41 (0) 61 206 40 14
F +41 (0) 61 206 40 01
M +41 (0) 79 446 25 21
E nick.miles@speedel.com
www.speedel.com
Frank LaSaracina
Managing Director
Speedel Pharmaceuticals Inc
1661 Route 22 West
P.O. Box 6532
Bridgewater, NJ 08807
United States of America
T +1 732 537 2290
F +1 732 537 2292
M +1 908 338 0501
E frank.lasaracina@speedel.com
www.speedel.com
Posted: June 2007
